WASHINGTON, 2nd March, 2016 (WAM) – As an additional safety measure against the emerging Zika virus outbreak, the U.S. Food and Drug Administration today issued new guidance for immediate implementation providing recommendations to reduce the potential transmission risk of Zika virus from human cells, tissues, and cellular and tissue-based products, HCT/Ps.
The guidance addresses donation of HCT/Ps from both living and deceased donors, including donors of umbilical cord blood, placenta, or other gestational tissues.
The new guidance is a part of the FDA’s ongoing efforts to protect HCT/Ps and blood products from Zika virus transmission. On February 16th, the FDA issued recommendations for reducing the risk of Zika virus via blood transfusion in the US.
“Though there is more to be learned about the transmission of Zika virus, given what we know about the virus at this point, which also is informed by our understanding of similar viruses, we must address the potential risk of Zika virus transmission by human cells and tissues,” said Peter Marks, Director of the FDA’s Centre for Biologics Evaluation and Research. “Providing HCT/P establishments with donor eligibility recommendations will help reduce that potential risk.”
There is a potential risk that the Zika virus can be transmitted by HCT/Ps used as part of a medical, surgical, or reproductive procedure. HCT/Ps include products such as corneas, bone, skin, heart valves, hematopoietic stem/progenitor cells (HPCs), gestational tissues such as amniotic membrane, and reproductive tissues such as semen and oocytes.
In addition to the guidance documents addressing the nation’s blood supply and HCT/Ps, the FDA continues to prioritise the development of blood donor screening and diagnostic tests that may be useful for identifying the presence of or recent infection with the virus, prepare to evaluate the safety and efficacy of investigational vaccines and therapeutics that might be developed, and review technology that may help suppress populations of the mosquitoes that can spread the virus.